Dermatitis, AtopicPhase 2NCT04086121

A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032

A Phase 2 study testing Spesolimab in people with Dermatitis, Atopic, run by Boehringer Ingelheim at 10 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032 Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Dermatitis, Atopic
What is being tested?: Spesolimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 10 sitesin 3 countries
Study dates: 24 Sep 2019to 23 Feb 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
Patients who completed the 1368-0032 trial and did not prematurely discontinue treatment prior to week 16, and; In the 1368-0032 re-allocation period (V7 to V11):
If an original non-responder from week 16 (V7), attained at least EASI 50 by last infusion (week 28) or by the EOS.
If an original responder from week 16 (V7) completed the last visit Week 28 (EOS) or dropped to a EASI 50 score prior to Week 28.
Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of the trial and 16 weeks after last study drug administration. A list of contraception methods meeting these criteria is provided in the patient information.

Who cannot join

Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Use of any restricted medication: or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
Active systemic infections during the last two weeks prior to first drug administration.
Currently enrolled in another investigational device or drug trial, except for 1368-0032.
Any condition which would prevent the patient continuing on treatment in this trial 1368-0037
Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse or any condition) other than AD, surgical procedure, psychiatric or social problems, medical examination finding (including vital signs and ECG), or laboratory value at the screening outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol, comply with all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the data.
History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

United States7 sites

Dermatology Treatment and Research Center, PA
Dallas, Texas, 75230
Clinical Physiology Associates
Fort Myers, Florida, 33912
Finlay Medical Research Corp
Miami, Florida, 33126
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
CCT Research
Scottsdale, Arizona, 85260
ForCare Clinical Research, Inc.
Tampa, Florida, 33613

Other trials in United States

Japan2 sites

Tennocho Ekimae Dermatology and Allergology
Kanagawa, Yokohama, 240-0004
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji, 193-0998

Other trials in Japan

Canada1 site

Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1

Other trials in Canada

About this study

Official title: An Open Label Extension Study to Assess the Long Term Safety of Treatment With BI 655130 Administered Subcutaneously in Adult Patients With Moderate to Severe Atopic Dermatitis

To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032

Conditions: Dermatitis, Atopic
Being tested: Spesolimab
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SpesolimabDrug
Also called BI 655130
Solution for SC injection

Study groups in NCT04086121
Study group	Role	What they receive
Spesolimab 600 mg	Experimental	600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks. All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit. Receives: Drug: Spesolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48
Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication.
Measured: From first dose until Week 48, up to 48 weeks.

Secondary outcomes (5)

Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. The percent change from baseline in EASI is calculated as: (EASI at week 48 - EASI at baseline) / EASI at baseline * 100%.
Measured: At baseline and at Week 48.
Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. [(EASI at week 48 - EASI at baseline) / EASI at baseline * 100%] ≥ 50%, then EASI50 = 1.
Measured: At baseline and at Week 48.
Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48
The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. [(EASI at week 48 - EASI at baseline) / EASI at baseline * 100%] ≥ 75%, then EASI75 = 1.
Measured: At baseline and at Week 48.
Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48
The SCORing of Atopic Dermatitis (SCORAD) index assesses elements: extent of disease, disease severity and subjective symptoms. The SCORAD consists of three elements: extent of disease, intensity of disease, and subjective symptoms (Pruritus and Sleep Loss). These 3 aspects: extent of disease (A: score range 0-1-2), disease severity (B: score range 0-18), and subjective symptoms (C: score range 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103 for SCORAD score. The SCORAD range from 0 (no disease) to 103 (severe disease). The higher the SCORAD score, the more severe the Atopic Dermatitis is.
Measured: At baseline and at Week 48.
Percentage of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator Global Assessment (IGA) at Week 48
The IGA scale allows investigators to assess overall disease severity at one given time point, and it consists of a five-point severity scale from clear to very severe disease (0= clear,1 =almost clear, 2 = mild disease, 3 = moderate disease, 4= severe disease). The IGA scale uses clinical characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment.
Measured: At baseline and at Week 48.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201923 Feb 2022

First posted11 Sep 2019
Study start24 Sep 2019
Primary completion28 Apr 2021
Study completion23 Feb 2022

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04086121
Sponsor's protocol ID: 1368-0037
Status last verified: Feb 2025
First submitted: 10 Sep 2019
Last updated: 24 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

All Dermatitis, Atopic trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Extension Study to Assess the Long Term Safety of Treatment With BI 655130 Administered Subcutaneously in Adult Patients With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT04086121
Acronym / sponsor ID: 1368-0037
Conditions: Dermatitis, Atopic
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 14 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 24 Sep 2019 (actual)
Primary completion: 28 Apr 2021 (actual)
Study completion: 23 Feb 2022 (actual)
First posted: 11 Sep 2019 (actual)
Results: Posted 18 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Spesolimab 600 mg	Experimental	Drug: Spesolimab600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks. All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
Patients who completed the 1368-0032 trial and did not prematurely discontinue treatment prior to week 16, and; In the 1368-0032 re-allocation period (V7 to V11):
Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of the trial and 16 weeks after last study drug administration. A list of contraception methods meeting these criteria is provided in the patient information.

Key exclusion criteria (8 listed)

Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Any new documented active or suspected malignancy except appropriately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Use of any restricted medication: or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
Active systemic infections during the last two weeks prior to first drug administration.
Currently enrolled in another investigational device or drug trial, except for 1368-0032.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SpesolimabAlso: BI 655130Solution for SC injection	Drug	Spesolimab 600 mg

Primary outcome

Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48
Time frame: From first dose until Week 48, up to 48 weeks.
Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication.

5 secondary outcomes

Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48
Time frame: At baseline and at Week 48.
Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48
Time frame: At baseline and at Week 48.
Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48
Time frame: At baseline and at Week 48.
Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48
Time frame: At baseline and at Week 48.
Percentage of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator Global Assessment (IGA) at Week 48
Time frame: At baseline and at Week 48.

Results and safety

Results posted to the registry on 18 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spesolimab 600 mg	14	0

Primary outcome: Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48

Time frame: From first dose until Week 48, up to 48 weeks.. Count of participants. Unit: Participants

Measure	Spesolimab 600 mg n = 14
Value	9

Population analysed: Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose until last dose + 16 weeks, up to 765 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spesolimab 600 mg	2 of 14 (14.3%)	11 of 14 (78.6%)	0 of 14

Limitations and caveats (from the sponsor): The study was terminated due to sponsor decision. The planned treatment period of 4 years was not reached.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Related trials for Dermatitis, Atopic

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Spesolimab in people with Dermatitis, Atopic, run by Boehringer Ingelheim at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Japan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48 (time frame: From first dose until Week 48, up to 48 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04086121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.